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Title: Controlled trial of anti-tuberculous chemotherapy for two years in Crohn's disease.
Title Abreviation: Gut Date of Pub: 1994 Mar
Author: Swift GL; Srivastava ED; Stone R; Pullan RD; Newcombe RG; Rhodes J; Wilkinson S; Rhodes P; Roberts G; Lawrie BW; et al;
Issue/Part/Supplement: 3 Volume Issue: 35 Pagination: 363-8
MESH Headings: Adolescence; Adult; Aged; Crohn Disease (*DT); Double-Blind Method; Drug Therapy, Combination; Ethambutol (*TU); Female; Human; Isoniazid (*TU); Male; Middle Age; Prednisolone (TU); Rifampin (*TU); Support, Non-U.S. Gov't; Time Factors; Treatment Outcome; -RN-;
Journal Title Code: FVT Publication Type: CLINICAL TRIAL
Date of Entry: 940512NEntry Month: 9407
Country: ENGLAND Index Priority: 1
Language: Eng Unique Identifier: 94200664
Unique Identifier: 94200664 ISSN: 0017-5749
Abstract: One hundred and thirty patients with active symptoms of Crohn's disease were treated in a double blind randomised controlled trial with rifampicin, isoniazid, and ethambutol, or identical placebos for up to two years. All other treatment considered necessary was continued. Analyses were based on 126 patients, 63 in each treatment group. Thirty seven in the active and 30 in the placebo group had previous surgical procedures. There was no difference in concomitant treatment between the two groups. Thirty in the active and 46 in the placebo groups were taking corticosteroids at entry to the trial. Forty eight of 63 patients in the active and 49 of 63 in the placebo group, completed at least 12 months' therapy. Reasons for early withdrawal included pregnancy, adverse reaction, and failure to comply. There was no significant difference in the mean number of months completed between the two groups. Nineteen adverse reactions were recorded for 17 patients in the active group compared with three reactions in patients on placebo. All of the nine patients withdrawn early because of adverse reactions were in the active group. Fifteen patients on active treatment and 14 on placebo had surgery during the trial with no difference in the type of surgery required between the groups. Radiological assessments based on 98 patients at the end of the trial showed no significant differences between groups in changes of extent of disease. More patients developed strictures on placebo compared with active treatment but without a statistically significant difference.(ABSTRACT TRUNCATED AT 250 WORDS)
Abstract By: Author
Address: Department of Gastroenterology, University Hospital of Wales, Cardiff.